Clinical Trial: ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy.

Detailed Summary:

OBJECTIVES: I. Determine the objective response in patients with refractory stage III or IV ovarian epithelial cancer treated with ILX-295501. II. Determine the number of patients with at least 50% decrease in CA125 when treated with this regimen. III. Determine the time to tumor progression, overall survival, and toxicity profile in this patient population treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive oral ILX-295501 once weekly for 3 weeks. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months until death.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study.

Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: May 2, 2000
Date Started: May 1999
Date Completion:
Last Updated: January 3, 2014
Last Verified: February 2001